Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial

BACKGROUND: Obese women have fewer oocytes retrieved, an increased cancelation rate, a higher miscarriage rate, and a lower live birth rate after assisted reproductive technology (ART) treatment compared with women with normal weight. Weight loss before ART treatment can significantly improve pregnancy rates and/or live births. An orlistat plus diet intervention could promote weight loss, but there is no evidence from randomized clinical trials evaluating the effect of orlistat preconceptional treatment on pregnancy outcome in overweight and obese women. METHODS/DESIGN: We are conducting a multicenter, randomized placebo-controlled, double-blind clinical trial in overweight and obese women aged 20–40 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) with or without intracytoplasmic sperm injection, to evaluate whether orlistat treatment for 1–3 months before IVF-ET can improve the live birth rate. The primary outcome is live birth. DISCUSSION: The results of this study will provide evidence for the effect of preconceptional orlistat treatment on IVF outcome in overweight/obese women. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-17011629. Registered on 11 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2780-7) contains supplementary material, which is available to authorized users.